QPharma advises sterile pharmacy compounders to comply with new GMP regulations

May 31 2014

QPharma, Inc. is advising sterile pharmacy compounders to be aware of their need to comply with new Good Manufacturing Practices (GMP) regulations.

In accordance with federal law, sterile pharmacy compounders that stockpile drug products are now required to register as Outsourcing Facilities — a completely new type of regulated business. Pending written agreements with each state, the U.S. Food and Drug Administration (FDA) is also prohibiting any compounding pharmacy from shipping more than 5 percent of its compounded products across state lines. Under this new classification, any sterile compounder that creates, fills, or packages a drug product without a specific prescription for each package created, or ships any appreciable amount of that product across state lines, is automatically considered an Outsourcing Facility and is subject to federal GMPs.

"Based on the numerous warning letters that have been issued in recent months, it appears that many compounders are unaware of their regulatory obligations," said Jeff Boatman, QPharma's Senior Subject Matter Expert, Quality Systems and Medical Devices. "Due to the newness of the regulation and the unprecedented degree of validation, it is not surprising that some pharmacies are struggling with compliance."

In addition to the GMP implications, individual state Boards of Pharmacy can dictate that sterile pharmacy compounders in their states are subject to process validation, regardless of their activities. For example, QPharma's home state of New Jersey has a pre-existing requirement that sterile compounders perform process validation initially for each drug class, and annually thereafter; while this regulation has been in effect for years, it has taken on new urgency as both federal and state regulatory authorities have begun aggressively inspecting compounders.

In its warning letters, FDA commonly recommends that compounders engage a third-party consulting firm for regulatory support. A leading compliance solutions firm, QPharma is at the ready to help sterile compounding pharmacies close potential compliance gaps and avoid significant penalties.